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Ionizing Radiation

Any radiation capable of displacing electrons from atoms or molecules, thereby producing ions. Examples include alpha, beta, gamma, and X-rays. High doses of ionizing radiation may produce severe skin or tissue damage.

IRB (Institutional) Authorization Agreement (IAA)

This agreement is used when one institution engages in research with: A performance site with whom institution ‘a’ currently does not have a Cooperative Review Agreement and Only one institution's IRB will review the study to avoid the need for dual review - Either institution ‘a’ or the performance site.

IRB No.

HUM number, include the HUM prefix in this field.

IRB-HSBS

Institutional Review Board for Health Sciences and Behavioral Science

ITS

Information and Technology Services

 

JARA

Junior Associate Regulatory Analyst

Justice

An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.

Lead Clinical Research Associate

Individual who manages the study protocol (i.e. consenting, IRB applications, scheduling patients, monitor visits, data entry, query resolution, etc.)

Legally Authorized Representative (LAR)

  1. Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. (FDA)
  2. A person authorized either by statute or by court appointment to make legal decisions on behalf of another person. In human subject research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

Limited Data Sets

Health information that excludes certain direct identifiers, but may include city, state, and ZIP code; elements of date; and other numbers, characteristics, or codes that cannot be used to identify an individual or the individual's relatives, employers, or household members. Limited data sets may be used or disclosed for purposes of research with a data use agreement as described by the HIPAA Privacy Rule at 45 CFR 164. For more information, including the list of identifiers that must be removed from health information in a limited data set, see HIPAA and Human Subjects Research.

Local Event / UM Event

An event which occurs in a study under the supervision of the UM IRBMED and whose principal investigator is a UM faculty or staff member. The event is a UM Event when it occurs at UM (including any UMHHC, or other facility) or any other site where the UM PI has oversight, even when the PI is physically in another location. It does not matter where the subject experiences or is treated for the adverse event. If interventions take place at several different UM locations, please specify at which location the event occurred.

Masked

The knowledge of intervention assignment. See Blind.

Masked Study Designs

Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects. Sometimes called "blind" study designs. See also: Double-Masked Design and Single-Masked Design

Material Transfer Agreement (MTA)

A MTA is a contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. Biological materials, such as reagentscell linesplasmids, and vectors, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds and even some types of software. Three types of MTAs are most common at academic institutions: transfer between academic or research institutions, transfer from academia to industry, and transfer from industry to academia. Each call for different terms and conditions.

Maximally Tolerated Dose

The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity.

MCRU

Michigan Clinical Research Unit

Medical Device

  • A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body (that is, not a drug or biologic). Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment. (OHRP)
  • A medical device is any instrument, apparatus, or other similar or related article, including component, part, or accessory, which is… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals… The range of devices is broad and diverse, including bandages, thermometers, ECG electrodes, IUDs, cardiac pacemakers, and hemodialysis machines. For further information, see the following FDA guidance:

Medical School

University of Michigan Medical School

MiChart

The patient-centric electronic health record (EHR) system used by more than 26,000 members of the Michigan Medicine community.

Michigan Billing Enrollment Calendar Tool (MBECT)

A tool to assist researchers with one point of data entry for building a clinical research budget and billing calendar and tracking your subject enrollment.

Michigan Clinical Research Unit (MCRU)

MCRU provides the clinical staff, resources, and infrastructure necessary to conduct human clinical research protocols at the UM. MCRU hosts investigators funded by federal, state, and local agencies as well as those funded by the private sector. MCRU also serves as an institutional resource for investigators to perform pilot studies that may result in further agency funding. Investigators whose research protocol is federally, departmentally, or philanthropically funded currently can access resources and services without fee. Industry-sponsored studies are billed differently but all research discounts apply.

Michigan Institute for Clinical and Health Research (MICHR)

MICHR’s mission is to enable & enhance clinical & translational research. Their aim is to make UM a world leader in translating scientific discoveries into real health gains. MICHR educates funds, connects, & supports research teams across U-M and the communities we serve. MICHR is proud to be a part of a national consortium of 60 medical research institutions working together with a common vision, funded through Clinical & Translational Science Awards (CTSA).

Michiganization

The process by which a specification (built & delivered by Nimblify) is updated by CRAO to encompass the level of detail needed for successful subject management, account reconciliation and charge routing at U of M.

MICHR

 Michigan Institute for Clinical and Health Research

MICHR IND/IDE Investigator Assistance Program (MIAP)

MIAP was established to provide comprehensive regulatory support, guidance, and education services to faculty investigators involved in US FDA regulated clinical research at UM. MIAP's primary focus is to offer regulatory assistance to sponsor-investigators of a new drug, biologic or medical device to ensure clinical research excellence and regulatory compliance, as set forth by the UM and the FDA. The MIAP program offers regulatory assistance to Investigators planning to utilize either a drug or biological product classified by the FDA as an IND per 21 CFR 312, or an investigational medical device subject to IDE regulations, per 21 CFR 812.

Mild Adverse Event

An event which does not pose any significant or permanent risk of harm to the subject. A mild adverse event is considered Grade Iusing CTC Common Toxicity Criteria. See also Severity.

Minimal Risk

  • Generally: “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life or during the performance of routine physical or psychological examinations or tests”  45 CFR 46.102(i)
  • Prisoners:  “Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy person"  45 CFR 46.303(d)

Minor Changes

Changes to research that in the judgment of the IRB do not affect assessment of the risks and benefits of the study by substantially altering any of the following: research aims or methodology, nature of subject participation, level of risk, proposed benefits, participant population, qualifications of the research team, or the facilities available to support the safe conduct of the research. A minor change does not increase risk more than minimally or add procedures in research categories other than those that qualify for expedited initial review.

Moderate Adverse Event

An event which causes discomfort and perhaps requires treatment, but does not pose any significant or permanent risk or harm to the subject or require in-patient hospitalization. An event that is Grade II by CTC Common Toxicity Criteria.

Modifications Required

An IRB action that specifies conditions under which research can be approved, pending the completion of minor, non-substantive (i.e., not directly relevant to the determinations required for approval by the IRB) clarifications or modifications to the protocol and/or informed consent process/document. Review of the investigator’s response(s) may be performed by expedited review.

Multi-site Trial

A single study that involves more than one research center.

Multicenter Research Project

A research project conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one set of investigators.

NCI

National Cancer Institute

NCRC

North Campus Research Complex

NCT Number

The protocol identifier assigned by clinicaltrials.gov.

Neonate

A newborn up to four weeks old.

NIAAA

National Institute on Alcohol Abuse and Alcoholism

NIDA

National Institute on Drug Abuse

NIH

 National Institutes of Health

NIMH

National Institute of Mental Health

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